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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Information (3190); Metal Related Pathology (4530)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Udi #: (b)(4).Concomitant medical devices: part: 00771101100, lot: 63393762; part: 00875705401, lot: 63385841; part: 00875101136, lot: 63382587.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03875, 0001822565-2020-03883, 0001822565-2020-03882.
Event or Problem Description
It was reported patient underwent a right hip revision procedure approximately nine years post implantation due to unknown reasons.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: h2, h3, h4, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a4, b4, b5, b7, g3, g6, h1, h2, h6, h10.The following sections were corrected: d4.
Event or Problem Description
It was reported that patient underwent right total hip arthroplasty and was subsequently revised 10 years later due to pain, instability, cup migration, liner wear, and metal related pathology.Operative note reported instability due to poly liner damage with vertically orientated acetabular component.Metallosis 2nd trunnion wear modular neck and stem interface.Tissue stained with gross greyish black metallosis type tissue on both acetabular and femoral components.Cup.Liner, head and stem revised.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent right total hip arthroplasty.Subsequently, patient underwent a revision procedure due to pain, instability and metal related pathology.Right hip posterior instability due to poly liner damage with vertically orientated acetabular component metallosis 2 nd trunnion wear at modular neck & stem interface.Right hip instability with occasional aches/pains; while golfing noticed clunking & clicking sensation.Tissues stained with gross greyish black metallosis type tissue.Attempted to remove neck from trunnion but was not easily removable.Removed cup: noted well-fixed in several areas (50%), but noted no bone attached upon removal.Device history record (dhr) was reviewed and no discrepancies were found.Additional information does not change the root cause of previous investigation.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 further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10869448
• Report Number: 0002648920-2020-00503
• Device Sequence Number: 3254189
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/16/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 61350162
• 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: 11/06/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 07/12/2021; 12/13/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/17/2020; 07/29/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2009
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG