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

Model Number	1570-02-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	10/25/2018
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
After review of medical record patient was revised to address failed left total hiparthroplasty secondary to metal on metal reaction.It was stated that the patient was implanted with asr xl component.Patient alleges gait disturbance, joint pain, joint wear, failure, elevated metal ions, and adverse soft tissue reaction.Revision notes stated that there was noted to be some pseudotumor embedded in the interval between the abductor and vastus lateralis origin and it was debrided.The joint fluid was encountered and appeared normal in appearance.There was fluid reaction with a pseudocapsule that extended into the anterior acetabulum which was debrided.Synovectomy was performed about the stem and the stem was noted to be well fixed.The acetabular component was noted to be in slight neutral version, but was noted to be well fixed using curved osteotome.Extensive synovectomy was performed to remove all the soft tissue reaction.Head and cup were removed.Doi: unknown - dor: (b)(6) 2018 (left hip).
Additional Manufacturer Narrative
Product complaint#: (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.H10 additional narrative: added: d4: (lot #).Corrected: h6 (patient code).H6 patient code: no code available (3191) used to capture the surgical intervention not device revision or replacement.

• Brand Name: SUMMIT DUOFIX TAP SZ5 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10191132
• Report Number: 1818910-2020-14376
• Device Sequence Number: 19587284
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1570-02-110
• Device Catalogue Number: 157002110
• Device Lot Number: A43GY1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT DUOFIX TAP SZ5 STD OFF; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT DUOFIX TAP SZ5 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73