MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a left total hip arthroplasty.Subsequently, approximately 3 months later, patient felt a pop a couple of times and manipulations were performed to correct the dislocations.Approximately one month later, patient underwent a revision due to the recurrent dislocations.During the revision, the posterior capsular structures were noted to be torn off the posterior greater trochanter and scarred down posteriorly over the sciatic nerve.Tissues were debrided around the proximal femur and dissected around the perimeter of the acetabular base.Large amounts of scar tissue were found anteriorly.The surgery was completed without complication and the head, taper, and liner were exchanged while the acetabulum and stem were found well fixed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref (b)(4) lot 65229971 m/l taper femoral stem size 12.5.Ref (b)(4) lot 64932913 tm shell with cluster holes, ref (b)(4) lot 65203293 self taping screw 6.5mm x 25mm, ref (b)(4) lot j7214208 self taping screw 6.5mm x 30mm, ref (b)(4) lot 65251232 kinectiv 12/14 neck taper- modular neck g, ref (b)(4) lot 3092461 biolox delta ceramic femoral head 32/0, taper 12/14, ref (b)(4) lot 0002376673 juggerknot soft anchor 2 # 2 maxbraid, ref (b)(4) lot 0002398343 juggerknot soft anchor 2 # 2 maxbraid.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: reported event was confirmed via medical records and radiographs reviewed by a health care professional.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to the patient not following instructions and performing movements that resulted in dislocations.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 information on the reported event.

• Brand Name: LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS
• 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: 15633027
• Report Number: 0002648920-2022-00220
• Device Sequence Number: 7997211
• Product Code: LPH
• UDI-Device Identifier: 00889024123755
• UDI-Public: (01)00889024123755(17)260218(10)64893916
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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 Expiration Date: 02/18/2026
• Device Model Number: N/A
• Device Catalogue Number: 00630505032
• Device Lot Number: 64893916
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 49 KG