MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 44X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103544000

Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # :(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the self centering head had a defect, that is, a gap that did not provide stability to the inside head.

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).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.

Event Description

Additional information received.A.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? this implant is made up of 2 pieces, that fit together.In the implant referred to in this complaint, the fitting was defective.There was a gap, that i couldn't bear to have.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, ¿the self centering head had a defect, that is, a gap that did not provide stability to the inside head.¿ the device associated with this report was returned to depuy synthes for evaluation.Examination of the device was not able to confirm the complaint.The device shows no evidence of failure or nonconformance.Reported condition was not able to be replicated.Additionally.No visual defects were observed on the implant.A dimensional inspection was performed for the self cent hip 44x28 gry and meets device specification.A functional test was not performed due to the mating device was not returned for evaluation.The overall complaint was unconfirmed as the observed condition of the device 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.-- dwg-103544000 rev.H current and manufactured.Outer diameter: drawing specification: 1.732 in +/-.005 in.Actual measurement: 1.7320 in pass inner diameter: drawing specification: 1.570 in.+/-.007in actual measurement: 1.5705 in pass.Device history lot : a manufacturing record evaluation was performed for the finished device product 103544000 , lot d23034782 , and no non-conformances / manufacturing irregularities were identified.Device history batch
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> a manufacturing record evaluation was performed for the finished device product 103544000 , lot d23034782 , and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SELF CENT HIP 44X28 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17435873
• MDR Text Key: 320149109
• Report Number: 1818910-2023-15700
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003342
• UDI-Public: 10603295003342
• 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,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103544000
• Device Lot Number: D23034782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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
• Treatment: SELF CENT HIP 44X28 GRY.; UNK HIP ACETABULAR LINER POLY.