IMP,TSV,MCOL MG,4.1MM,13M
Report
- Report Number
- 0002023141-2022-01187
- Event Type
- Injury
- Date Received
- May 13, 2022
- Date of Event
- July 24, 2020
- Report Date
- October 17, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019645
- PMA / PMN Number
- K111889
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4).
SIMILAR COMPLAINTS FOR INFECTION AND / OR BONE LOSS RELATED PROBLEMS HAVE BEEN PREVIOUSLY INVESTIGATED. INVESTIGATIONS PERFORMED FOR HUNDREDS OF EVENTS WHERE EITHER OF THESE CONDITIONS, INFECTION OR BONE LOSS, OR BOTH, HAVE BEEN REPORTED, HAVE CONCLUDED THAT THE LIKELY CAUSE(S) FOR THE IMPLANT FAILURE IN RELATION TO THESE CONDITIONS ARE EXTERNAL FACTORS. THOSE INCLUDE, MEDICAL CONDITIONS (E.G., DIABETES, BRUXISM, ETC.), PATIENT HABITS (E.G., SMOKING, BAD ORAL HYGIENE ROUTINE) AND USER ERROR (E.G., SURGICAL TECHNIQUE). THERE HAS NOT BEEN ANY INSTANCE WHERE EITHER INFECTION AND/OR BONE LOSS, HAVE RESULTED FROM A MANUFACTURING OR DESIGN DEFECT. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO INFECTION AND RESULT IN BONE LOSS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THE ANALYSIS AND RESULT OF INVESTIGATIONS AND THE ANALYSIS OF PROBABILITY PREVIOUSLY DESCRIBED ARE CONTAINED IN THE SUMMARY INVESTIGATION REPORTS PERFORMED FOR BONE LOSS AND INFECTION, WHICH ARE ATTACHED. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/IE ESCALATION. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242670. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD OP# 160 - STR2 WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1242670 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: MEDICAL: INFECTION & MEDICAL: BONE LOSS. AS DOCUMENTED IN THE SUMMARY INVESTIGATIONS, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATIONS, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENTS REMAIN NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION. SECTIONS UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY AND PRODUCT RETURN DATE. G3: DATE INVESTIGATION RESULTS WERE RECEIVED. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED. H6: ADVERSE EVENT PROBLEM CODES. H10: MANUFACTURER'S NARRATIVE.
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND AN ABSCESS AT THE SITE. TOOTH #19.
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1835310 | IMP,TSV,MCOL MG,4.1MM,13M | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVM4B13 | 1242670 | 00889024019645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention |