MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. WITH CONSTRAINING RING CEMENTED CONSTRAINED LINER; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient dislocated less than one month post implantation.It was reported that the cemented constrained liner was implanted correctly into the burch ring with no dislocation of the cup or ring.It was reported that the correct size head was dislocated from the socket.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D1: 36mm i.D.With constraining ring cemented constrained liner use with 58mm o.D.Shell / do not use with skirted heads.D10: 00877703601 biolox⮠option, head, s, 㸠36/-3.0, taper 12/14 3185256 g2: foreign: switzerland 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
This follow-up report is being submitted to relay additional and/or corrected information.Corrected: h4.Updated: d4, g3, g6, h2, h3, h6.Visual examination of the returned product identified the backside of the liners shows damages most likely coming from the revision surgery.Of note, no traces of cement was found on the backside of the liner.The articulating surface of the liner shows some scratches and rough areas, however it is not possible to determine if they are due to the revision surgery or if they happened during the time in vivo.The metal ring shows some scratch but it is overall inconspicuous.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip arthroplasty dislocation as noted with suspected limited depth of the acetabular fossa as noted.This would be best evaluated by examining the entire ct series.A definitive root cause cannot be determined.This complaint was confirmed based on the review of the mmi report confirming the reported event.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: 36MM I.D. WITH CONSTRAINING RING CEMENTED CONSTRAINED LINER
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19642743
• Report Number: 0001822565-2024-02179
• Device Sequence Number: 7146352
• Product Code: KWZ
• UDI-Device Identifier: 00889024130289
• UDI-Public: (01)00889024130289(17)280627(10)65539843
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/14/2024

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: 00711505836
• Device Lot Number: 65539843
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown