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

Catalog Number	157002110
Medical Device Problem Codes	Malposition of Device (2616); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Inflammation (1932); Tissue Damage (2104); No Code Available (3191)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: initial reporter occupation: lawyer.(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
Medical records received.It was indicated that the patient was revised to address recurrent dislocation.The patient had dislocated thrice prior to being revised.During the surgery, there was a large amount of cottage cheese-like material in the subcutaneous area with a cystic membrane consistent with a subcutaneous bursa which appeared to be inflammatory.There was also presence of a dark watery serosanguineous fluid consistent with trauma from the dislocation.There was a small nick in the stem which the surgeon thought was caused by the stem impinging with the previously revised asr implants.The stem was also noted to be anteverted.The surgeon noted that the reason for the dislocation was due to the absence of posterior tissue.The femoral head was stained with multiple stripes of titanium debris.A large fibroma was discovered which contributed to the posterior instability through impingement of soft tissue.Doi: (b)(6) 2018 - dor: (b)(6) 2018, (left hip).Previous revision involving asr xl implants is on (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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 SZ5 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8522796
• Report Number: 1818910-2019-90900
• Device Sequence Number: 16635645
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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 Expiration Date: 01/31/2017
• Device Catalogue Number: 157002110
• Device Lot Number: BC1CJ1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR