CER OPTION TYPE 1 TPR SLEVE +3
Report
- Report Number
- 3002806535-2020-00225
- Event Type
- Injury
- Date Received
- April 8, 2020
- Date of Event
- March 13, 2020
- Report Date
- November 6, 2020
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- UDI-DI
- 00887868271496
- PMA / PMN Number
- K192683
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE DEVICE WHICH WAS IMPLANTED DURING THE REVISION WAS REPORTED IN ERROR. MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE +3, CATALOG # 650-1067, LOT # 2942374. THIS REPORT WILL BE VOIDED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2020-00226-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. X_RAY REVIEW: THREE ANTEROPOSTERIOR (AP) RADIOGRAPHS: ONE PRE-PRIMARY ((B)(6) 2020), ONE PRE-REVISION ((B)(6) 2020) AND ONE POST-REVISION ((B)(6) 2020) WERE PROVIDED WITH (B)(4). THE ABOVE MENTIONED DATES WHEN RADIOGRAPHS WERE TAKEN ARE INFERRED FROM THE INFORMATION PRINTED ON EACH RADIOGRAPH. THE PATIENT SUFFERED DISLOCATION IN RECOVERY ROOM JUST AFTER THE PRIMARY SURGERY. THE PRE-REVISION AP RADIOGRAPH SHOWS THAT THE FEMORAL HEAD IS NOT CONCENTRIC WITHIN THE ACETABULAR SHELL, CONFIRMING THE REPORTED DISLOCATION. INTRAOPERATIVE X-RAYS HAVE BEEN MENTIONED IN THE OPERATIVE REPORT OF THE PRIMARY SURGERY PROVIDED WITH (B)(4), HOWEVER NO INTRAOPERATIVE OR IMMEDIATE POST-PRIMARY FULL PELVIS RADIOGRAPHS ARE AVAILABLE TO EVALUATE THE INITIAL SIZE, POSITION AND ALIGNMENT OF THE COMPONENTS. THE POST-REVISION SURGERY AP RADIOGRAPH SHOWS THAT THE SURGEON USED A BONE SCREW TO IMPROVE FIXATION OF THE ACETABULAR SHELL AND A CABLE TIE WITH A CRIMP TO SUPPORT THE FEMORAL BONE SURROUNDING THE STEM. THIS SUGGESTS THE PRESENCE OF A POOR BONE STOCK, WHICH MAY HAVE CONTRIBUTED TO THE DISLOCATION OF THE PRIMARY COMPONENTS. THE OPERATIVE REPORT FOR THE POST-DISLOCATION REVISION SURGERY PROVIDED WITH (B)(4) MENTIONS THAT THE HEAD WAS REMOVED AND TRIAL COMPONENTS WERE TRIED TO TRY TO GET FURTHER LENGTH. EVENTUALLY, A +9 COMPONENT WAS PLACED, BUT THE HIP STILL SUBLUXED. IT WAS THOUGHT THEREFORE A HIGH WALL LINER WOULD BE BENEFICIAL. THE PATIENT THEN HAD THE FEMORAL COMPONENT EXAMINED AND IT APPEARED TO BE LOOSE WITH MULTIPLE TRAILS. IT WAS REMOVED. A CABLE WAS CRIMPED AROUND THE PROXIMAL FEMUR AND THEN THE FEMUR WAS RE-BROACHED. THE PRIMARY SURGERY TAPERLOC/G7 SYSTEM COMPONENTS WERE REVISED WITH A HIGH-OFFSET 18X156 MM TYPE 1 PPS FEMORAL STEM, A LARGER 40 MM CERAMIC BIOLOX OPTION HEAD WITH +3 MM TYPE 1 TAPER SLEEVE, AND A G7 HIGH-WALL 40 MM E1 LINER. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE G7 NEUTRAL E1 LINER HAVE BEEN EVALUATED IN AN ASSOCIATED COMPLAINT ((B)(4)). MHRS FOR THE REMAINING IMPLANT COMPONENTS FROM THE TAPERLOC/G7 SYSTEM HAVE NOT BEEN PROVIDED AT THE TIME OF WRITING THIS REPORT AND THEREFORE CANNOT NOT BE CHECKED. BASED ON THE INFORMATION PROVIDED IN THE OPERATIVE REPORTS, THE SHORT TAPER NECK LENGTH AND LOOSE FEMORAL COMPONENT DURING THE PRIMARY SURGERY, COMBINED WITH A DEGREE OF JOINT LAXITY, MAY HAVE CONTRIBUTED TO THE DISLOCATION. HOWEVER, THIS CANNOT BE CONFIRMED WITH THE PROVIDED INFORMATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESMENT: RISK MANAGEMENT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES HIP REVISION DUE TO DISLOCATION. IN THE RISK FILE, DISLOCATION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION IN POSTOP RECOVERY ROOM. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP SO THE PATIENT WAS BROUGHT BACK TO THE OR FOR A REVISION SURGERY.
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION IN POSTOP RECOVERY ROOM. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP SO THE PATIENT WAS BROUGHT BACK TO THE OR FOR A REVISION SURGERY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED.
(B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED BY THE HOSPITAL. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 40MM, CATALOG # 650-1058, LOT # 2904573, MEDICAL PRODUCT: TPRLC 133 T1 PPS HO 18X156MM CATALOG # 51-104180, LOT # 6466410, MEDICAL PRODUCT:BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH CATALOG # 00625006525, LOT # 64567716, MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2020-00226. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION IN POSTOP RECOVERY ROOM. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP SO THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A REVISION SURGERY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405157 | CER OPTION TYPE 1 TPR SLEVE +3 | HIP PROTHESIS | LPH | BIOMET UK LTD. | N/A | 2942374 | 00887868271496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |