MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER WITH CONSTRAINING RING; PROSTHESIS, HIP

Catalog Number	00633405832
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat #: 00877703202/ biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / lot #: 2992422 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient underwent revision procedure due to a dislocation the liner and head were removed and replaced.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified ring is no longer attached.Ceramic head remains seated upon return.Lot is hard to capture in the photo but was able to be confirmed during evaluation.Liner shows nicks and scratches to all areas.Anti rotation scallops show indentation damage.Liner tabs are deformed and exhibit gouge damage.Constraining ring shows scratches from use.Metal abrasion damage is noted on the top side and the raised area from head dislocation.No other damage noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised approximately four years post implantation due to pain and recurrent dislocations.A constrained liner and ceramic head were placed.The patient was revised a second time another four years later due to a dislocation.A closed reduction was attempted in the er, but ultimately the head and liner were revised with another constrained liner and ceramic head.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: displacement of the constraining portion of the right hip arthroplasty.The complaint was confirmed based on the returned device and medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause was 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.

• Brand Name: CONSTRAINED LINER WITH CONSTRAINING RING
• Common Device Name: PROSTHESIS, HIP
• 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: 17730135
• Report Number: 0001822565-2023-02471
• Device Sequence Number: 15055676
• Product Code: KWZ
• UDI-Device Identifier: 00889024126107
• UDI-Public: (01)00889024126107(17)240331(10)64268755
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K071718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 00633405832
• Device Lot Number: 64268755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2019
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White