MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; HIP FEMORAL STEM

Model Number	1570-11-135
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scar Tissue (2060); Anxiety (2328); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	04/02/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.
Event or Problem Description
Litigation record received.On or about (b)(6) 2008, patient was implanted with asr hip in the left hip.On or about (b)(6) 2022, patient was revised.Litigation alleged pain, discomfort, elevated metal in bloods including cobalt and chromium.Doi: (b)(6) 2008; dor: (b)(6) 2022; 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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Medical records reported that on (b)(6) 2022, the patient was revised due to total hip arthroplasty and fractured prothesis.Operative noted an extensive metallosis and necrosis and extensive scar of the fractured stem.Acetabular shell noted to have osteolysis around edges and behind the acetabular component there was extensive osteonecrosis and osteolysis with significant black metallosis tissue.All devices were explanted and replaced with a zimmer hip implants.
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.Update 26-jun-2023 update received on jun 21, 2023 did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
In addition to what previously alleged, pfs alleges dislocation, limping while walking and anxiety.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16875996
• Report Number: 1818910-2023-09719
• Device Sequence Number: 15269448
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: 10603295060086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-11-135
• Device Catalogue Number: 157011135
• Device Lot Number: CD1H71000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 06/26/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2008
• 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: ASR ACETABULAR CUPS 58; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 51; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 93 KG