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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Concomitant medical products: item number 110024464 item name g7 dual mobility liner 44mm f lot # 896290.Item number 00811400210 item name femoral stem 12/14 neck taper ext.Offset size 2 130 mm stem length lot # 64441079.Item number ep-200160 item name act artic e1 hip brg 28x54mm s60 dia28 lot # 012620.The device will not be returned for analysis as was not returned by hospital; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure approximately nine months post implantation due to dislocation.No additional information on the reported event is available at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11087195
• Report Number: 0002648920-2020-00543
• Device Sequence Number: 16322261
• Product Code: LPH
• UDI-Device Identifier: 00889024144620
• UDI-Public: (01)00889024144620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00801802802
• Device Lot Number: 64455813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/09/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 98