MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-135

Device Problem Degraded (1153)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: litigation alleges pain and elevated metal ion levels.Asr litigation records received.Litigation alleges injuries, suffering and emotional distress.Plaintiff is seeking compensatory damages.After review of the medical records the patient was revised to address adverse local tissue reaction.Operative note reported adverse local tissue reaction within the hip capsule, synovial thickening, cup have significant bony ingrowth but was not grossly loose.A scant of fluid obtained due to the thickening of synovium and it was turbid yellow colored due to stained by blood.Some trunnion corrosion and there was scratches of the head due to removing the implant.There was slight amount of heterotopic ossification in the anterior capsule.Doi: (b)(6) 2009.Dor: (b)(6) 2018; right hip.

• Brand Name: SUMMIT POR TAPER SZ7 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10074668
• MDR Text Key: 191551700
• Report Number: 1818910-2020-12330
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059387
• UDI-Public: 10603295059387
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 1570-01-135
• Device Catalogue Number: 157001135
• Device Lot Number: D57DR1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2009
• 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: 77 YR