MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SUMMIT POR TAPER SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient alleges having progressive pain in her right hip that is exacerbated by weightbearing activities.X-ray showed no abnormalities, but the metal levels remained elevated.Repeat metal levels in (b)(6) 2021 showed that the metal levels have continued to rise.Revision surgery has been recommended on her right hip.The curved osteotome/easy out system was utilized in standard fashion to disrupt the interface between the bone and the acetabular component which was noted to be osseointegrated.There was minimal iatrogenic bone loss with removal of the acetabular component but given the components placement both medially and retroverted and relatively large size for the patient's anatomy there was not a lot of bone remaining.Doi : (b)(6) 2010, dor: (b)(6) 2021, righ hip affected side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.

• Brand Name: SUMMIT POR TAPER SZ3 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16120511
• Report Number: 1818910-2023-00760
• Device Sequence Number: 6382813
• Product Code: LPH
• UDI-Device Identifier: 10603295059349
• UDI-Public: 10603295059349
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2023

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 Expiration Date: 10/01/2018
• Device Model Number: 1570-01-090
• Device Catalogue Number: 157001090
• Device Lot Number: C44E51000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 POR TAPER SZ3 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 82 KG