MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ1 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-070
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.For the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
New ecm record created in order to update legacy complaint (b)(4).Patient was revised to address a malpositioned cup causing wear of the liner.Cup was noted to have been placed in 65 to 70 degrees of inclination.Update ad 16 apr 2019: (b)(4) has been reopened under (b)(4) due to receipt of pinnacle claim submission form and medical records via cd shipment last 04 apr 2019.After review of medical records, the patient was revised to address a failed total hip arthroplasty with pain, popping and clicking.There was some marked synovitis which had a darkish stain to it.The surgeon suspected that the patient was having problems with metal wear and metal debris.However, upon inspection of the neck trunnion, there was no significant wear on the neck trunnion.There were a couple of minor scratches but it was not considered significant.There was wear on cup and it was noted to be asymmetrical.The stem was noted to be stable and there was no evidence of loosening.Post-operatively, the patient had anemia due to blood loss.Two units were given to the patient.Lab results taken from (b)(6) 2015 show elevated cobalt and chromium levels.Added lawyer, law firm, medical history, relevant test/lab data an patient date of birth.An impacted product record for the head, liner and stem was added.Updated the primary surgery date.Doi: (b)(6) 2008.Dor: (b)(6) 2016, (right 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: h6 (patient).No code available (3191) is used to capture synovitis.

• Brand Name: SUMMIT POR TAPER SZ1 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: 9102255
• Report Number: 1818910-2019-105696
• Device Sequence Number: 14233759
• Product Code: LPH
• UDI-Device Identifier: 10603295059325
• UDI-Public: 10603295059325
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1570-01-070
• Device Catalogue Number: 157001070
• Device Lot Number: A25B61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 08/07/2020
• 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: 71 YR
• Patient Weight: 73