MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1035-40-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon had a patient with a 40 mm bipolar head and 40 mm +4 10 degree liner in situ.He had to remove the self centering bipolar head because the poly insert in the head¿s rim that clips into big metal head, broke.Patient status/outcome/consequences: yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional 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. .
Event or Problem Description
Additional information received that the patient experienced pain and immobility.There was no surgical delay and when patient presented with pain and immobility, surgeon had x-rays done and saw the position of the femoral head implant was altered and decided to have it revised.The affected side was the right hip and the date of implantation was 2018.
Additional Manufacturer Narrative
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.H10 additional narrative: product complaint (b)(4).Investigation summary: the device was reviewed by bioengineering and a report was received stating it is not possible to determine if a potential product issue was present root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SELF CENT HIP 40X28 RUST
• Common Device Name: 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: 9375692
• Report Number: 1818910-2019-118013
• Device Sequence Number: 11535903
• Product Code: KWY
• UDI-Device Identifier: 10603295003304
• UDI-Public: 10603295003304
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1035-40-000
• Device Catalogue Number: 103540000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 01/14/2020; 01/16/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/26/2019; 01/27/2020; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +1.5 GR; ARTICUL/EZE BALL 28 +1.5 GR
• Outcome Attributed to Adverse Event: Required Intervention