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

Catalog Number 103543000

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

It was reported that there was a gap between the polyethylene and the dome.

Manufacturer Narrative

Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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).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 : according to the information received, ¿the implant below was opened yesterday for an emergency surgery, however it was not used because it has a gap between the polyethylene and the dome.¿ the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device was not able to confirm the complaint since no gap between the polyethylene component and the metal shell was observed.A 0.20 mm pin gage was utilized to verify that no gaps were present between the components of the device.However, deformation on the orifices of the poly collar was observed most likely caused by attempting to remove the component from the device.A manufacturing record evaluation were performed for the finished device 103543000, lot number d22112552, it was manufactured on 15-nov-2022.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.The overall complaint was unconfirmed as the observed condition of the self cent hip 43x28 gry would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation were performed for the finished device 103543000, lot number d22112552, it was manufactured on 15-nov-2022.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.Device history review : a manufacturing record evaluation were performed for the finished device 103543000, lot number d22112552, it was manufactured on 15-nov-2022.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.Corrected h3.

• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17656378
• MDR Text Key: 322429036
• Report Number: 1818910-2023-17917
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003335
• UDI-Public: 10603295003335
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103543000
• Device Lot Number: D22112552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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