MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR +3MM NECK; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient was revised twelve days post op due to dislocation.Per sales rep's, the version of the acetabular cup was too anteverted and the origination of the highwall liner was causing leverage making the femoral head dislocate anteriorly.Surgeon believes the origination of the cup was fine and that it was due to a non-compliant patient.The patient had a shuffle gait and did not want to follow post operative protocol, per surgeon.The stem, head, and liner were exchanged.No allegations against the stem as it was removed because the surgeon knocked the femoral head hard dislodging the stem.
Additional Manufacturer Narrative
(b)(4).D10: 010000925 g7 hi-wall e1 liner 32mm c 6956867.51-116140 tprlc 133 mp type1 bm so 14.0 6977535.010000701 g7 bonemaster ltd acet shl 48c 7482911.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01825.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Proposed component code mechanical (g04) - head.Visual examination of the provided pictures identified the head/liner/stem laying in a tub with blood on it.No other information could be obtained from the images.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: right hip arthroplasty dislocation with abnormal cup anteversion as noted.A definitive root cause cannot be determined.The event is confirmed via provided xrays.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: 32MM MOD HEAD COCR +3MM NECK
• Common Device Name: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17470889
• Report Number: 0001825034-2023-01829
• Device Sequence Number: 5961987
• Product Code: JDG
• UDI-Device Identifier: 00887868308345
• UDI-Public: (01)00887868308345(17)300825(10)64850341
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163670
• Device Lot Number: 64850341
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Prefer Not To Disclose