MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SUMMIT POR TAPER SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Claim letter received, claim letter had no allegation mentioned regarding patient depuy hip implant.Doi: (b)(6) 2009.Dor: (b)(6) 2020.Affected side left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.No device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.Wwcapa (b)(4) superseded by mdd capa-(b)(4) was established regarding root cause and/or corrective actions.Reference: mdd capa-(b)(4).(b)(4)- (b)(6) 2022.Update ad 21 dec 2022: (b)(4) was reopened due to receipt of medical records, after review of file name - (b)(4) medical records ad (b)(6) 2022, patient was revised due to increasingly painful left hip, describing pain as aching and burning.Pain experienced in the groin area and back.Patient led to quit job due to the significant pain & swelling.Despite quitting job, pain was ongoing.Patient noticed popping and squeaking in the left hip.Additionally, elevated metal levels showed that the metal levels have continued to rise.Extensive soft tissue debridement was performed of all grossly necrotic or metallic stained tissue.The left side went onto developed gross failure of pseudotumor and a loose acetabular component.Doi: (b)(6) 2009.Dor: (b)(6) 2020.Affected side left hip.Added patient identifiers: initials, dob, age, height and weight.Medical history.Associated contacts.Impacted products ( based on the sticker sheets ) concomitant products.Facility name.Doi: updated from 08/02/2009 to 08/20/2009.Initial reporter occupation: lawyer.(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 SZ4 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: 16111394
• Report Number: 1818910-2023-00599
• Device Sequence Number: 6811758
• Product Code: LPH
• UDI-Device Identifier: 10603295059356
• UDI-Public: 10603295059356
• 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: 2009
• Device Explanted Year: 2020
• 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): 01/06/2023

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: 05/01/2019
• Device Model Number: 1570-01-100
• Device Catalogue Number: 157001100
• Device Lot Number: DV3DHA
• 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: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2009
• 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 52.; ASR UNI FEMORAL IMPL SIZE 46.; SUMMIT POR TAPER SZ4 STD OFF.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female