MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157012120

Device Problem No Apparent Adverse Event (3189)

Patient Problems Necrosis (1971); Tissue Damage (2104); No Code Available (3191)

Event Date 03/19/2019

Event Type  Injury  

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 Description

Samples taken at the time of the first washout ((b)(6)) failed to grow any bacteria/infection - captured as (b)(4).On (b)(6) 2019 the surgeon however was concerned that the extensive necrotic tissue surrounding the proximal femur would result in later issues and decided to remove all components and insert a temporary cement spacer.The femoral component was removed causing damage to the proximal femoral bone.A cement spacer inserted and the proximal femur cabled.Black metallosis was evident around the femoral taper (images uploaded to ecm).The acetabular component was removed, while maintaining acetabular bone and integrity.Male patient initials (b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no devices were returned for evaluation.A review of complaint databases did not identify any anomalies.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8496683
• MDR Text Key: 141367660
• Report Number: 1818910-2019-90216
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 157012120
• Device Lot Number: WH9DM1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2002
• 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
• Patient Outcome(s): Required Intervention