MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. XLPE 10 DEG POLY LINER 62X36; 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	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00877703604 ¿ biolox head ¿ 2946703.00620006222 ¿ shell ¿ 61976148.00771101120 ¿ femoral stem ¿ 61904690.Reported event was confirmed by review of medical records noting that patient underwent a right hip revision and experienced 2 dislocations shortly after.Each dislocation resulted in a closed reduction.Placement of a knee immobilizer was conducted after the second dislocation.X-rays were reviewed and no fractured or other findings were found.Dhr was reviewed and no discrepancies were found.The root cause is 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
It was reported that patient underwent a right hip revision approximately 8 years post implantation.Approximately 2 months later, the patient experienced a dislocation and a second dislocation approximately 2 weeks later.A closed reduction was performed for both instances.No revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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.Additional medical records were provided, with new patient information; height 6'5", weight 215 lbs, bmi 25.5.Device history record (dhr) was reviewed and no discrepancies were found.Root cause remains unchanged.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: XLPE 10 DEG POLY LINER 62X36
• 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: 11878056
• Report Number: 0002648920-2021-00130
• Device Sequence Number: 19085015
• Product Code: LPH
• UDI-Device Identifier: 00889024124912
• UDI-Public: (01)00889024124912(17)230131(10)63909778
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2022

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 Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00631006236
• Device Lot Number: 63909778
• 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: 05/17/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 01/20/2022
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 01/19/2022; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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: Other
• Patient Sex: Male
• Patient Weight: 98 KG