MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP SROM

Catalog Number UNK HIP ACETABULAR CUP SROM

Device Problem Off-Label Use (1494)

Patient Problem Unspecified Infection (1930)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 on an unknown date or dates and location of previous surgeries.No implant or lot information is available however it is believed to be an srom oblong cup with constrained liner and a porous coated profile stem.Patient presents in office with gross infection.Taken to surgery as soon as possible for resection arthroplasty of total hip replacement.Gross puss is present once opened in high volume.Femoral stem is removed along with femoral head ball, liner and screws.Cup is well fixed and with very little bone left in acetabular area, surgeon choses to leave in place.A thorough i&d is performed.A dual set up is utilized to cement a liner into the existing shell, place a new femoral component along with resorbable antibiotic beads in the bones and soft tissues.No patient harm occurred and no instruments were broken.Doi: unknown, dor: on (b)(6) 2023, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR CUP SROM
• Type of Device: HIP ACETABULAR CUP
• 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: 17030713
• MDR Text Key: 316294859
• Report Number: 1818910-2023-11198
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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 Catalogue Number: UNK HIP ACETABULAR CUP SROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FEMORAL HEAD BALL.; PROFILE STEM, POROUS COATED.; SROM ACETABULAR SCREW.; SROM ACETABULAR SCREW.; SROM CONSTRAINED LINER.
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 39 KG