MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 43X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-43-000

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the bipolar head was defective when opened sterile onto filed.The locking mechanism between the poly and the shell did not seat.Poly would slide and move within metal head.Dr.Did not feel comfortable using.Original implant date unknown.No surgical delay.Doi: unknown, doe: (b)(6) 2021, affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the reported upon receipt damaged condition was not confirmed, however, the investigation revealed the components not locking together as intended.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : review of the dhr¿s for the finished good lot j44h01 as well as the collar component lots that were utilized (j4265m, j4265r) did not identify any anomalies in the manufacturing or process history within the warsaw site.No issues were noted in terms of incorrect subcomponent numbers being used to assembly this lot of product.Device history review : a dhr review was performed for the finished device lot number j44h01, and no non-conformances or manufacturing irregularities were identified.

• Brand Name: SELF CENT HIP 43X28 GRY
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12532358
• MDR Text Key: 273319772
• Report Number: 1818910-2021-21147
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003335
• UDI-Public: 10603295003335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-43-000
• Device Catalogue Number: 103543000
• Device Lot Number: J44H01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female