MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ASPHERE M SPEC 11/13 36 +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136531100
Medical Device Problem Codes	Material Disintegration (1177); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
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 will be re-opened as necessary.(b)(4).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
It was reported that the metal liner was changed out to poly.
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.Additional narrative: corrected: (device codes) 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 will be re-opened as necessary.Update 20-june-2019: the investigation was re-opened upon receipt of new information.The additional information does not affect the previous investigation.Device history lot null.Device history batch null.Device history review null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASPHERE M SPEC 11/13 36 +0
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8245396
• Report Number: 1818910-2019-80825
• Device Sequence Number: 14069345
• Product Code: JDI
• UDI-Device Identifier: 10603295033370
• UDI-Public: 10603295033370
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: 136531100
• Device Lot Number: 3154405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR