MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON 10D 52OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1220-32-152
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 patient was revised due to poly wear.Doi: (b)(6) 2001.Dor: (b)(6) 2020.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The device was implanted in calendar year 2001.Poly material after this long implanted would not be unreasonable to expect.The information received will be retained for potential series investigations if triggered by trend analysis 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.H10 additional narrative: added: d4 (lot #), d11, g5 and h4.Corrected: d1, d2b, d4 (catalog and udi).

• Brand Name: ENDURON 10D 52OD X 28ID
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10523344
• Report Number: 1818910-2020-19903
• Device Sequence Number: 19650101
• Product Code: HRY
• UDI-Device Identifier: 10603295015536
• UDI-Public: 10603295015536
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 1220-32-152
• Device Catalogue Number: 124152025
• Device Lot Number: U2PFB1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +8.5 BL; DURALOC DYNAMIC LOCK RING 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 47