CER BIOLOXD MOD HD 36MM -3 NK
Report
- Report Number
- 3002806535-2020-00232
- Event Type
- Injury
- Date Received
- April 28, 2020
- Date of Event
- March 15, 2020
- Report Date
- September 9, 2020
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- PMA / PMN Number
- K061312
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H10. ADDITIONAL INFORMATION RECEIVED: -ON (B)(6) 2020, A SUPERFICIAL I&D WAS PERFORMED FOR WOUND DEHISCENCE. -THE OUTCOME IS PENDING.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF STERILE CERTIFICATE CONFIRM PRODUCT RECEIVED ADEQUATE AMOUNT OF RADIATION ACCORDING TO STANDARD SPECIFICATION. RISK ASSESSMENT: THE ROOT CAUSE OF THE REPORTED EVENT OF DELAYED WOUND HEALING COULD NOT BE DETERMINED WITH THE INFORMATION RELATED TO THE DEN PROVIDED TO DATE. THEREFORE A SPECIFIC LINE RELATING TO A HAZARD COULD NOT BE SELECTED FOR ASSESSMENT. THERE IS NO INFORMATION THAT SUGGESTS THIS EVENT IS VICE AND SO RISK ASSESSMENT CANNOT BE CONDUCTED, IF ANY FURTHER INFORMATION IS PROVIDED RISK SHOULD BE REASSESSED. 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 H3 OTHER TEXT : PRODUCT HAS NOT BEEN RETURNED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING WITH DRAINAGE. MEDICAL INTERVENTION WAS PROVIDED, AND THE OUTCOME IS PENDING. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2020, A SUPERFICIAL I&D WAS PERFORMED FOR WOUND DEHISCENCE. THE OUTCOME IS PENDING.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING WITH DRAINAGE. MEDICAL INTERVENTION WAS PROVIDED, AND THE OUTCOME IS PENDING. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2020, A SUPERFICIAL I&D WAS PERFORMED FOR WOUND DEHISCENCE. THE OUTCOME IS PENDING. NO ADDITIONAL INFORMATION AVAILABLE. FINAL MDR REPORT.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 54F, CATALOG #: 010000664, LOT #: 662979. MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 36MM F, CATALOG #: 010000858, LOT #: 6623312. MEDICAL PRODUCT: ECHO POR FMRL LAT NC 9X125MM, CATALOG #: 192109, LOT #: 925910. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING WITH DRAINAGE. MEDICAL INTERVENTION WAS PROVIDED, AND THE OUTCOME IS PENDING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470361 | CER BIOLOXD MOD HD 36MM -3 NK | HIP ARTHROPLASTY | LZO | BIOMET UK LTD. | N/A | 2986013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |