CMK MOD 12/14 SZ202 L130
Report
- Report Number
- 3002806535-2026-00008
- Event Type
- Injury
- Date Received
- January 8, 2026
- Date of Event
- October 24, 2025
- Report Date
- January 16, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 03599870015322
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: RINGLOC BIPOLAR VIT E 28X41MM; ITEM# 30302841; LOT# 66941912. DELTA CER FM HD 028/0MM 12/14; ITEM# 650-0831; LOT# 3197555. G2 - FOREIGN: JAPAN. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K192236. H11 - AN INITIAL REPORT WAS ALREADY SUBMITTED FOR THIS EVENT, BUT UNDER THE INCORRECT MFR NUMBER. PLEASE SEE REPORT NUMBER 3006946279-2025-00124 FOR REFERENCE. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. UPON COMPLETION OF INVESTIGATIONS, REASSESSMENT HAS FOUND THAT THE EVENT IS NOT REPORTABLE. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: PATIENTS ARE ASSESSED PRIOR TO SURGERY TO DETECT ANY RISKS FOR CARDIAC COMPLICATIONS; HOWEVER, AT TIMES EVEN WITH A COMPLETE WORK UP, A PATIENT MAY EXPERIENCE CARDIAC ISCHEMIA. THE STRESS OF SURGERY CAN LEAD TO MYOCARDIAL ISCHEMIA OR INFARCTION VIA MULTIPLE MECHANISMS INCLUDING CORONARY ARTERY PLAQUE RUPTURE AND MYOCARDIAL DEMAND ISCHEMIA. THIS LEADS TO CARDIAC DYSFUNCTION CAUSED BY INSUFFICIENT BLOOD FLOW TO THE CORONARY ARTERIES. THIS AT TIMES MAY BE MASKED DUE TO ANESTHESIA. THIS IS A PROCEDURAL RELATED COMPLICATION DUE TO THE STRESS OF SURGERY AND NOT RELATED TO A DEVICE. PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. THIS IS A LIMITED INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. 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.
IT WAS REPORTED THAT DURING A PROCEDURE, AS THE STEM WAS BEING INSERTED AND SECURED, THE SURGEON WAS ALREADY RESPONDING TO CHANGES IN THE PULSE OF THE PATIENT. THESE CHANGES PROGRESSED TO A TEMPORARY CARDIAC ARREST. GAUZE WAS PACKED INTO THE SURGICAL SITE, AND THE PROCEDURE ON THE AFFECTED AREA WAS TEMPORARILY HALTED. CARDIAC MASSAGE WAS INITIATED, AND THE ATTENDING PHYSICIAN STEPPED AWAY TO INFORM THE PATIENT¿S FAMILY OF THE SITUATION. FOLLOWING THE RETURN OF CARDIAC ACTIVITY, A TRIAL WAS PERFORMED, AFTER WHICH THE FEMORAL HEAD AND ACETABULAR CUP WERE IMPLANTED AND THE WOUND WAS CLOSED. MEASURES WERE TAKEN TO STABILIZE THE PATIENT¿S HEARTBEAT. THE ATTENDING PHYSICIAN CONFIRMED THAT THERE WERE NO ISSUES WITH THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66137 | CMK MOD 12/14 SZ202 L130 | HIP PROSTHESIS | LZO | BIOMET UK LTD. | 0001866625 | 03599870015322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other| H | SEE H11 NARRATIVE. |