MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 52X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103552000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/02/2024

Event Type  Injury  

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.

Event Description

It was reported that the patient returned to surgery for infection.The hip was washed out and a new head and bipolar were placed.No delays.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record review of clean process and sterilization process was performed for the finished device d23032548, and no non-conformances/manufacturing irregularities were identified.Product code 103552000, lot no.D23032548 of quantity (b)(4) was sterilized on 25-mar-2023.Per the sterilization certificate, the sterilization cycles met the validated parameters.Details refer to the attachments ¿work order for d23032548¿ and ¿sterilization certificate for d23032548¿.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record review of clean process and sterilization process was performed for the finished device d23032548, and no non-conformances/manufacturing irregularities were identified.Product code 103552000, lot no.D23032548 of quantity (b)(4) was sterilized on 25-mar-2023.Per the sterilization certificate, the sterilization cycles met the validated parameters.Details refer to the attachments ¿work order for d23032548¿ and ¿sterilization certificate for d23032548¿.

• Brand Name: SELF CENT HIP 52X28 BLU
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19088551
• MDR Text Key: 339927520
• Report Number: 1818910-2024-08106
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003427
• UDI-Public: 10603295003427
• 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: 04/11/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 103552000
• Device Lot Number: D23032548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/10/2024; 05/09/2024
• Supplement Dates FDA Received: 04/16/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2024
• 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: ARTICUL/EZE BALL 28 +5 BR
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 88 KG