MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 130 MM STEM LENGTH; PROSTHESIS, HIP

Catalog Number	00811400100
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately nine years post implantation, patient is presenting with pain and a pseudotumor was found on an x-ray.To date, no revision has been scheduled.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02706, 0002648920-2023-00237, 0002648920-2023-00238.D10: cat #: 00877503601 / biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 / lot #: 2651987 cat #: 00877501136 / biolox⮠delta ceramic taper liner, size jj / 36 i.D.For use with 54 mm o.D.Size jj shell / lot #: 2727208.Cat #: 00875705401 / 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners / lot #: 62590993.Cat #: 00625006530 / bone screw self-tapping 6.5 mm dia.30 mm length / lot #: 62619015, cat #: 00625006520 / bone screw self-tapping 6.5 mm dia.20 mm length / lot #: 62619024.G2: scotland/united kingdom.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 will be submitted.
Event or Problem Description
It was reported a patient underwent a hip revision approximately nine years post implantation due to pain and a pseudotumor.During the procedure, inflammation and implant wear were noted.The shell was well fixed and remains implanted.The stem, liner, and head were removed and replaced.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were not provided.A letter was provided from the surgeon and reviewed by a hcp, which describes findings on components of implant wear and pseudotumor/inflammation.The complaint cannot be confirmed.A definitive root cause cannot be determined.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.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified trunnion shows wear from use.Distal stem and contoured radius show abraded damage.Nicks and scratches were noted along the length of the stem from use and explant.No other damage was noted.Complaint was confirmed based on the returned device showing wear.Root cause unchanged.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.

• Brand Name: FEMORAL STEM 12/14 130 MM STEM LENGTH
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17868196
• Report Number: 0002648920-2023-00236
• Device Sequence Number: 7041959
• Product Code: JDI
• UDI-Device Identifier: 00889024145757
• UDI-Public: (01)00889024145757(17)240131(10)62586389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 00811400100
• Device Lot Number: 62586389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 01/25/2024; 05/22/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/21/2023; 01/31/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown