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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Joint Laxity (4526); Muscle/Tendon Damage (4532)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00620205422 lot 64933082 shell with cluster holes tm 54mm.Ref 00625006530 lot j7214200 self tapping bone screw 6.5x30mm.Ref 00625006525 lot j7189408 self tapping bone screw 6.5x25mm.Ref 00877503202 lot 3087528 head biolox delta ceramic 32/0, taper 12/14.Ref 00784802300 lot 65251229 neck taper kinectiv 12/14.Ref 00771300700 lot 64708522 stem kinectiv cementless pressfit size 7.5.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient had a left total hip arthroplasty.Six weeks post-op, she anteriorly dislocated the hip while clipping her toenails and experienced ongoing pain.The physician noted that with the deformity in the patient¿s back, she would be more likely to dislocate again.The patient anteriorly dislocated 3-4 more times before being revised approximately eight (8) months after initial surgery.During the revision, upon opening of the capsule, the hip was found dislocated, the joint had the appearance of chronic anterior hip dislocation, and the posterior capsular tissues were somewhat torn.The taper, head, and liner were exchanged without complication.Attempts have been made and no further information has been provided.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.On (b)(6) 2022, office visit on going pain, dislocation 6 weeks post op while clipping toenails and internally rotated and flexed hip, on (b)(6) 2023, dislocated again 2/3 times, tissue damage, some laxity of the anterior structure.Cup and stem stable no other complications.The patient was noted to have dislocated while clipping her toenails and this is not to post-op care, it was also noted that there was some laxity of the anterior structure.It's unknown if the patient's anatomy or non-compliance was related to the root cause of the dislocations.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.

• Brand Name: LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS
• Type of Device: 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: 16264162
• MDR Text Key: 308368005
• Report Number: 0001822565-2023-00207
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024123755
• UDI-Public: (01)00889024123755(17)260218(10)64893916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG