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

Model Number 1035-52-000

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

Patient Problem Pain (1994)

Event Date 11/18/2020

Event Type  Injury  

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 patient had a tha on left hip by the surgeon on (b)(6) 2018.On (b)(6) 2018, the patient was revised due to a failed cup, and a bipolar head was implanted.The patient returns to have a conversion of the bipolar hip to a total due to recurrent hip pain.The only implant retained from original primary surgery is corail.Appeared the stem was anteverted during the original implantation and this may have attributed to the pain of the bipolar.Doi: (b)(6) 2018, dor: (b)(6) 2020, affected side: left hip.

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 stating that there was no surgical delay.It appeared the stem was anteverted during original implantation and this may have attributed to the pain of the bipolar implanted on (b)(6) 2022 and possible revision on (b)(6) 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A singular x-ray image has been reviewed.Depicted in the singular image is the stem, head and self-centering acetabular device.It was not possible to identify any issue with stem positioning, or any other product problem in the provided image.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 10959957
• MDR Text Key: 219962894
• Report Number: 1818910-2020-26357
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003427
• UDI-Public: 10603295003427
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-52-000
• Device Catalogue Number: 103552000
• Device Lot Number: HZ2724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 12; DLT TS CER HD 12/14 28MM +1.5; CORAIL2 STD SIZE 12; DLT TS CER HD 12/14 28MM +1.5
• Patient Age: 51 YR