MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: p0561e56 avantage e1 inlay s56 / 28 0001631404.Report source: foreign: country: south africa.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a left hip revision approximately three months post implantation due to dislocation.During the procedure, the insert and femoral head were removed and replaced.At six weeks post operation, no dislocation was observed.During the holiday season, the patient fell resulting in dislocation of the same hip.A second revision was done on the left hip at the beginning of the year where it was discovered that the femoral head came out of the insert.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, h2, h3, h6.Component code: mechanical (g04)-head no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with evidence of polyethylene wear versus dislocation on (b)(6) 2022.Extensive heterotopic ossification surrounds the left hip joint, of uncertain etiology.Absent left greater trochanter.A definitive root cause cannot be determined.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROTHESIS, 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: 16293616
• Report Number: 0002648920-2023-00008
• Device Sequence Number: 17755672
• Product Code: LPH
• UDI-Device Identifier: 00889024144613
• UDI-Public: (01)00889024144613(17)320424(10)65341383
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 03/17/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00801802801
• Device Lot Number: 65341383
• Was Device Available for Evaluation?: No
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 130 KG