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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 10/25/2018

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

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).

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
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10191132
• MDR Text Key: 196317228
• Report Number: 1818910-2020-14376
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• 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,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1570-02-110
• Device Catalogue Number: 157002110
• Device Lot Number: A43GY1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73