TPRLOC COCR CMTD STM T1 12.5MM
Report
- Report Number
- 3002806535-2026-00130
- Event Type
- Death
- Date Received
- March 24, 2026
- Date of Event
- January 12, 2022
- Report Date
- May 13, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JDI
- UDI-DI
- 00887868350382
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4) D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: ITEM NAME# RINGLOC BI-POLAR 28X47MM; ITEM NUMBER# 11-165218; LOT NUMBER# UNKNOWN. ITEM NAME# 28MM MOD HD STD NECK TP1 TAPER; ITEM NUMBER# 163662; LOT NUMBER# UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN NETHERLANDS. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K071723. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THIS IS A LIMITED INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: PERIOPERATIVE STROKE IS DEFINED AS A BRAIN INFARCTION OF ISCHEMIC OR HEMORRHAGIC ETIOLOGY THAT OCCURS DURING SURGERY OR WITHIN 30 DAYS AFTER SURGERY. THE GREATEST RISK FACTORS FOR POSTOPERATIVE STROKE INCLUDE A HISTORY OF STROKE, INCLUDING TRANSIENT ISCHEMIC ATTACK, ADVANCED AGE, ANEMIA (HEMATOCRIT <27%), AND RENAL DYSFUNCTION. MOST PERIOPERATIVE STROKES OCCUR ON POSTOPERATIVE DAYS 2¿9. SURGERIES THAT ARE AT PARTICULARLY HIGH RISK INCLUDE EMERGENCY SURGERY, VASCULAR SURGERY (SUCH AS CAROTID ENDARTERECTOMY AND THORACIC ENDOVASCULAR AORTIC REPAIR), AND BRAIN SURGERY. SINCE MOST PERIOPERATIVE STROKES IN NONCARDIAC, NON-NEUROLOGICAL SURGERY ARE ISCHEMIC IN NATURE, THEY ARE TYPICALLY ATTRIBUTED TO HYPOTENSION AND/OR LOW-FLOW STATES, PREVIOUSLY UNDISCLOSED LARGE-ARTERY STENOSIS, ANEMIA-ASSOCIATED TISSUE HYPOXIA, EMBOLISM (THROMBUS, FAT, OR FOREIGN MATERIAL), ENHANCED COAGULABILITY OR THROMBOSIS IN THE SETTING OF SYSTEMIC INFLAMMATION, AND/OR RECENT DISCONTINUATION OF ANTITHROMBOTIC MEDICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. UPON COMPLETION OF THE INVESTIGATION REASSESSMENT WAS FOUND THAT THE EVENT IS NOT REPORTABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, B7, D4, D10, E1, E2, E3, G3, G6, H2, H4, H6, H11. D10: ITEM NAME# RINGLOC BI-POLAR 28X47MM; ITEM NUMBER# 11-165218; LOT NUMBER# 994990. ITEM NAME# 28MM MOD HD STD NECK TP1 TAPER; ITEM NUMBER# 163662; LOT NUMBER# 246360. 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.
IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST HIP IMPLANTATION, THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT AND PASSED AWAY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238246 | TPRLOC COCR CMTD STM T1 12.5MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | JDI | BIOMET UK LTD. | 7089710 | 00887868350382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |