MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001110

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 06/03/2014

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.(b)(4).

Event Description

Litigation alleges patient had pain after asr hip implant.There is no new information that would change the outcome of the investigation.Update ad 10 apr 2019.Receipt of medical records and sticker sheets.After review of medical records, the patient was revised to address pain, metallosis and elevated blood cobalt and chrome levels.Operative findings include an effluent cloudy fluid and synovitis.The fluid was sent for culture and gram staining which resulted to presence of white blood cells with no organisms seen.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 STD 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-XXXX ; 6107428552
• MDR Report Key: 8573076
• MDR Text Key: 143815098
• Report Number: 1818910-2019-92234
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059363
• UDI-Public: 10603295059363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157001110
• Device Lot Number: AY4FA1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2006
• 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
• Patient Age: 69 YR