36MM COCR MOD HD -3MM
Report
- Report Number
- 0001825034-2025-00909
- Event Type
- Injury
- Date Received
- April 1, 2025
- Date of Event
- December 12, 2024
- Report Date
- July 7, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- UDI-DI
- 00880304210516
- PMA / PMN Number
- K032396
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: 010000665 ITEM NAME G7 PPS LTD ACET SHELL 56F LOT # 3369449 010000856 ITEM NAME G7 NEUTRAL E1 LINER 36MM D LOT # 3302876 51-104160 ITEM NAME TPRLC 133 T1 PPS HO 16X152MM LOT # 324848 H6: COMPONENT CODE: HEAD THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D10: D10: 010000665, ITEM NAME: G7 PPS LTD ACET SHELL 56F, LOT # 3369449. 010000856, ITEM NAME: G7 NEUTRAL E1 LINER 36MM D, LOT # 3302876. 51-104160, ITEM NAME: TPRLC 133 T1 PPS HO 16X152MM, LOT # 3242848. 010000998, ITEM NAME: G7 ACETABULAR SCREW, LOT # 3287626.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;D4;G3;H2;H3;H4;H6;H10 IT HAS BEEN DETERMINED THAT THE EVENT IS NOT RELATED TO THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REPORTED EVENT IS NOT RELATED TO THE DEVICE THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT LATERAL HIP PAIN AND SYMPTOMS CONSISTENT WITH TROCHANTERIC BURSITIS. NO FURTHER ACTIONS WILL BE INITIATED AS A RESULT OF REPORTED EVENT. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE (THE FLUID FILLED SAC THAT CUSHIONS THE JOINT) AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE TO THE BURSAE. BURSITIS IS A VERY COMMON CONDITION THAT CAN IMPACT ANY OF THE JOINTS AND CAN LAST FOR A SHORT DURATION OR YEARS. SYMPTOMS THE PATIENT CAN EXPERIENCE INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. CONSERVATIVE TREATMENT CONSISTS OF OVER THE COUNTER (OTC) MEDICATIONS PAIN RELIEVERS AND ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND APPLYING PRESSURE WRAPS. IF CONSERVATIVE TREATMENTS FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOP BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION FOR TREATMENT. 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.
IT WAS REPORTED THAT 10 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED LEFT LATERAL PAIN CONSISTENT WITH TROCHANTER BURSITIS. PATIENT TOOK OVER THE COUNTER MEDICATION (NSAIDS) AND OUTPATIENT THERAPY WERE ADMINISTERED AND THE IMPLANTS REMAIN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1171074 | 36MM COCR MOD HD -3MM | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | 160920 | 00880304210516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | PLEASE SEE H11.| PLEASE SEE H11. |