COMPREHENSIVE AUGMENT MINI BASEPLATE WITH TAPER MD
Report
- Report Number
- 0001825034-2020-00079
- Event Type
- Injury
- Date Received
- January 3, 2020
- Date of Event
- August 29, 2019
- Report Date
- May 1, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- PMA / PMN Number
- K172502
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PRIMARY OP NOTES AND PREOP NOTES WERE REVIEWED AND NO COMPLICATIONS WERE NOTED. CRF MEDICAL NOTES WERE REVIEWED AND IDENTIFIED THE FOLLOWING. 6 WEEK VISIT : REVIEWED RECORD WITHOUT ANY SIGNIFICANT FINDINGS. ASES: ROM & ADL¿S IMPROVING, STABILITY INCREASING. IMPROVEMENT WITHOUT OVERALL EQ-5D. AP AND AXILLARY RADIOGRAPHS TAKEN WITHOUT SIGNIFICANT FINDINGS. ADVERSE EVENT DAYS AFTER: RIGHT SHOULDER HEMATOMA ASPIRATED AND NOTED TO BE RESOLVED. 6 MONTH VISIT: AP AND AXILLARY RADIOGRAPHS TAKEN WITH FINDING OF HETEROTOPIC OSSIFICATION AT THE INFERIOR GLENOID ZONES 1-3. ASES: ROM, ADLS AND STABILITY IMPROVED FROM PRE-OPERATIVE FINDINGS. EQ-5D: IMPROVEMENT FROM PRE-OPERATIVE EXCLUDING MOBILITY WHICH NOW NOTES MODERATE PROBLEMS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO (RELATED) DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE FOR THE REPORTED ISSUES ARE RELATED TO THE PROCEDURE AND ARE NOT ABNORMAL TO THE PROCEDURE. NO FAILURE DETECTED WITH THE DEVICES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
UPON REASSESSMENT OF THE REPORTED EVENT, THE BASEPLATE WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 0001822565-2020-00167. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, THE BASEPLATE WAS REPORTED CORRECTLY ON THE INITIAL REPORT UNDER 0001825034-2020-00079. PLEASE DISREGARD MEDWATCH 0001825034-2020-00079-1 AS IT WAS SUBMITTED IN ERROR.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
UPON REASSESSMENT OF THE REPORTED EVENT, THE BASEPLATE WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 0001822565-2020-00167. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, THE BASEPLATE WAS REPORTED CORRECTLY ON THE INITIAL REPORT UNDER 0001825034-2020-00079. PLEASE DISREGARD MEDWATCH 0001825034-2020-00079-1 AS IT WAS SUBMITTED IN ERROR.
(B)(4). PRODUCT CODE: PHX/ UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 13MM MINI M MINI CAT# 113633 LOT# 996880, MINI HUMERAL TRAY +5 MM THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER CAT 110031400 LOT# 64336369, BEARING +3 MM THICKNESS 40 MM DIAMETER CAT# 110031422 LOT# 64291297, GLENOSPHERE STANDARD OFFSET 40 MM DIAMETER CAT# 110030776 LOT# 11024225, COMP RVS CNTRL 6.5X25MM ST/RST CAT# 115395 LOT# 840070, COMP LK SCR 3.5HEX 4.75X15 ST CAT# 180550 LOT# 462580, COMP LK SCR 3.5HEX 4.75X15 ST CAT# 180550 LOT# 206550, COMP LK SCR 3.5HEX 4.75X30 ST CAT# 180553 LOT# 750870, COMP LK SCR 3.5HEX 4.75X30 ST CAT# 180553 LOT# 028290. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00078 0001825034 - 2020 - 00080 0001825034 - 2020 - 00081 0001825034 - 2020 - 00082 0001825034 - 2020 - 00083 0001825034 - 2020 - 00084
IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE AN ASPIRATION OF A HEMATOMA APPROXIMATELY 45 DAYS LATER. THE PATIENT WAS ALSO NOTED TO HAVE HETEROTOPIC OSSIFICATION AT THE 6-MONTH FOLLOW-UP; HOWEVER, NO INTERVENTION WAS NOTED AT THIS TIME AND THE PATIENT CONTINUES TO HAVE IMPROVED OUTCOME MEASURES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5095 | COMPREHENSIVE AUGMENT MINI BASEPLATE WITH TAPER MD | PROSTHESIS, SHOULDER | KWS | ZIMMER BIOMET, INC. | NI | 64155088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |