MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136543500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	10/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that his patient underwent an srom modular metal on metal construct roughly 10 years ago - done by doctor.It is unknown whether or not this patient's previous surgery was performed at (b)(6) hospital or at (b)(6) rockies and it is unknown the exact date.The patient lives in (b)(6) and recently his blood work lab results came back showing a higher incidence of metal ion count in the blood.His labs also show an increased chance of infection in his hip.He was revised today to a poly liner and metal head.The metal liner and previous metal were removed.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11/13 S-ROM 40MM M SPEC+3
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9361731
• Report Number: 1818910-2019-117517
• Device Sequence Number: 13981877
• Product Code: LPH
• UDI-Device Identifier: 10603295033776
• UDI-Public: 10603295033776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2019

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 Catalogue Number: 136543500
• Device Lot Number: 2753102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 12/17/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/18/2019; 12/20/2019
• 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: 72 YR
• Patient Weight: 93