MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. OBLIQUE LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL; 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	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item number 00-8758-010-28 item name continuum longevityconstrained liner, ii 28 x 52 lot # 64030604.The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -02961.
Event or Problem Description
It was reported that a patient underwent a tha.Subsequently a revision was done for dislocated hip one month post implantation.Removed the liner and replaced with a constrained liner.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for the liner identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to the off-label usage, by using a competitor head with a zimmer liner.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.

• Brand Name: OBLIQUE LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
• 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: 12674317
• Report Number: 0002648920-2021-00338
• Device Sequence Number: 1231379
• Product Code: JDI
• UDI-Device Identifier: 00889024150911
• UDI-Public: (01)00889024150911(17)231031(10)64030590
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00875501036
• Device Lot Number: 64030590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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 Weight: 57