MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 45 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch 3500a will be submitted.Concomitant medical products: 00500104428/bipolar liner 44/45/46mm od x 28mm id/65299025.00877502803/biolox delta fem head, 28mm, +3.5mm/3090897.01.06010.001/avenir mller stem 1 standard/ 2955598.
Event or Problem Description
It was reported a patient underwent a left hemiarthroplaty on.Subsequently, the patient underwent a revision to a total hip arthroplasty due to recurring dislocations approximately 1 month later.During the procedure, mild laxity was noted to the soft tissues and scar tissue was debrided to increase internal rotation.All components except the stem were removed and replaced.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a hemiarthroplasty.During a follow up, the patient had minimal pain with imaging done, where the pelvis was noted to be well positioned and appropriate length.If dislocations occurred, a revision would be considered.Since the follow up, the patient experienced reoccurring dislocations and underwent a revision.Laxity of soft tissues was found and scar tissue debrided.The shell, liner, and head were removed and replaced with total hip zimmer products and no complications were noted.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 additional event information to report at this time.

• Brand Name: SHELL 45 MM O.D.
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15267093
• Report Number: 0002648920-2022-00178
• Device Sequence Number: 5732520
• Product Code: KWY
• UDI-Device Identifier: 00889024115330
• UDI-Public: (01)00889024115330(17)320509(10)65341078
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Model Number: N/A
• Device Catalogue Number: 00500104500
• Device Lot Number: 65341078
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG