MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ5 HI; HIP FEMORAL STEM/SLEEVE

Catalog Number	157013110
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Weakness (2145); Discomfort (2330); Osteolysis (2377)
Date of Event	07/22/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient was revised to address pain, elevated metal ion levels, and bone fracture of the trochanter.Clinical der was also received on 7/25/2014 stating revision due to osteolysis.Update jul 17, 2017: litigation received.Litigation alleges defective pinnacle hip had caused damage to patient's hip joint and body.Added complainant information.This complaint was updated on aug 7, 2017.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pfs alleges discomfort, limping, weakness, pseudotumor and metallosis.The stem was already added.Added lot numbers of the impacted products, patient harms, revision hospital, law firm, patient's and lawyer in the associated contact.
Additional Manufacturer Narrative
Udi: (b)(4).
Event or Problem Description
Ppf alleges metal wear.
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.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
Complaint description: patient was revised to address pain, elevated metal ion levels, and bone fracture of the trochanter.Clinical der was also received on 7/25/2014 stating revision due to osteolysis.Update jul 17, 2017: litigation received.Litigation alleges defective pinnacle hip had caused damage to patient's hip joint and body.Added complainant information.This complaint was updated on aug 7, 2017.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT CEMENTED STEM SZ5 HI
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6794691
• Report Number: 1818910-2017-22763
• Device Sequence Number: 1735450
• Product Code: JDI
• UDI-Device Identifier: 10603295060246
• UDI-Public: 10603295060246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/17/2017

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: 05/20/2009
• Device Catalogue Number: 157013110
• Device Lot Number: YT6CB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 05/17/2018; 09/25/2018; 01/01/2019; 11/04/2019
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 05/21/2018; 09/26/2018; 01/03/2019; 11/05/2019
• 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: 78 YR
• Patient Weight: 70