MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACS POLY 20D 28 GR2; ACS HIP LINERS : HIP POLY ACETABULAR LINERS

Model Number	1115-27-025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Additional information indicated that according to the surgeon there was a head and liner change in 1989 and 1999, but it is unknown whether a der was reported at the time for either of those two events.
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 the revision for instability and polyethylene wear.Dictation records indicated the cup and liner was a 50mm aml 2 and the head ball size was a 32mm.Based on that information we ordered in aml/tl enduron liners 32mm sp from expresscare for the case.It was discovered that intraoperatively, dr.Dictation notes were incorrect and the patient actually had an acs acetabular cup and liner with a 28mm +8.5 ceramic head ball.Dr decided to cement a 46mm pinnacle marathon liner inside the existing acs cup.He implanted an articuleze 28 +8.5 metal head ball and put the hip through a range of motion to confirm stability and confirmed hip was stable.They used off label.Doi: (b)(6) 1988; dor: (b)(6) 2020; affected side.
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).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 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 : 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: ACS POLY 20D 28 GR2
• Common Device Name: ACS HIP LINERS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9706201
• Report Number: 1818910-2020-04717
• Device Sequence Number: 2396440
• Product Code: HRY
• UDI-Device Identifier: 10603295004875
• UDI-Public: 10603295004875
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K944538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1988
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: 1115-27-025
• Device Catalogue Number: 111527025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 03/19/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 02/28/2020; 03/22/2020
• 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: 76 YR