MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00630505036, xlpe liner, 64313299.00625006525, bone screw, 64256558.00620005022, acetabular cup, 63344850.Unknown cls porous stem, lot number 299192.Report source (b)(6).Visual review of photographs provided identified that the rim of the liner had fractured.Radiographs were provided and reviewed by a third party hcp noting a dislocation of the left hip arthroplasty.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A summary of the investigation was requested by the customer and has been sent.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00263.
Event or Problem Description
It was reported that patient underwent a left hip revision approximately 9 months post implantation due to fracture of the liner component.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COCR FEMORAL HEAD
• 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: 10309731
• Report Number: 0002648920-2020-00355
• Device Sequence Number: 2309856
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 00801803602
• Device Lot Number: 64350090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/22/2020
• 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
• Patient Age: 65 YR