MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121731056
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/17/2018
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.
Event or Problem Description
Der stated that patient had hip pain and saxony surgeon didn't like the cup position.Took out the cup, liner and head put in a new cup and head.It was also reported that proximal part of the stem appears loose at the bone to implant interface, cement manufacturer is unknown, as they could wiggle it with an osteotome between the neck and the greater trochanter.Used osteotomes and slap hammers to try to extract stem for an hour but stem too fixed distally so left in stem and used hydroset around the stem to refixate.Doi: (b)(6) 2016; dor: (b)(6) 2018; left hip.No surgical delay.
Additional Manufacturer Narrative
(b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PINN 100 W/GRIPTION 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7258770
• Report Number: 1818910-2018-53094
• Device Sequence Number: 1177385
• Product Code: JDI
• UDI-Device Identifier: 10603295010227
• UDI-Public: 10603295010227
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 121731056
• Device Lot Number: H06502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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: 66 YR