MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS 1818910 SELF CENT HIP 46X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-46-000

Device Problem Difficult to Insert (1316)

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

Event Date 01/04/2021

Event Type  malfunction  

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

Surgeon is complaining the fit between the inlay and the metal shell in the self centering bipolar head.A larger clearance of the components than in the past was observed and clarification was requested.Surgery was finished anyhow, an adverse patient consequence was not reported, a surgical delay was not reported.

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: review of manufacturing records was performed by depuy engineering and found all products in this lot passed inspection prior to release from manufacture according to the dhr.

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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A.Did the event occur during primary or revision surgery? answer: it occured during primary surgery b.Please provide the product and lot number of the self cent hip that were not implanted.Answer: this was a translation error by silke hess-köth.No alternative product was available, so ref (b)(4), lot j73u96 was implanted.

• Brand Name: SELF CENT HIP 46X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; randall; warsaw IN 46581 0988
• MDR Report Key: 11257799
• MDR Text Key: 229580708
• Report Number: 1818910-2021-02165
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003366
• UDI-Public: 10603295003366
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-46-000
• Device Catalogue Number: 103546000
• Device Lot Number: J73U96
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR