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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 00633405028 lot number:64165806 brand name: trilogy liner, unknown stem, unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04651, 0001822565-2019-04653.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to reduced mobility and a mri scan suggesting some localized tissue abnormalities around the hip prosthesis.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
The reported head was returned and visual inspection of the head identified scratches on the bottom surface around the taper, and on the spherical surface.No other damages were noted.Complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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 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
• MDR Report Key: 9569333
• Report Number: 0002648920-2020-00023
• Device Sequence Number: 16292478
• Product Code: LPH
• UDI-Device Identifier: 00889024144620
• UDI-Public: (01)00889024144620
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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 Model Number: N/A
• Device Catalogue Number: 00801802802
• Device Lot Number: 64309632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention