MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN LNR CON +4 10D 36IDX58OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121836758
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that the surgeon tried to put in a constrained liner, and the first one he tried he messed up the poly reducing the hip.He then used the second constrained liner and he put the locking ring on backwards.He messed with that for prob 30 min until he realized it was backwards.I had showed him the text guide before, but i could not get close enough furring the case to see how he put the ring on.He ended up damaging the seven liner then he chose to implant a 40 bipolar head in a 40 liner.He felt it was stable and he closed.It was further clarified that the surgeon felt like the head was too tall when he first tried to reduce the femoral head into the constrained liner.As he was pulling really hard the femoral head drag across the lip of the liner and damaged it.After it was damaged from the reduction of the femoral head, he then unreduced the hip and tried the back up constrained liner we had.He used a shorter femoral head to not hurt the lip of the liner as be reduced it, but he put the capture ring on backwards.He was trying for around 30 min to get the capture ring on the second liner until he finally realized the ring was on backwards and the beveled edge was pointing away from the poly and not towards as it should have been.He felt bad and then went to a standard liner and head.Unknown hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN LNR CON +4 10D 36IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8451440
• Report Number: 1818910-2019-88447
• Device Sequence Number: 223154
• Product Code: KWA
• UDI-Device Identifier: 10603295012160
• UDI-Public: 10603295012160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121836758
• Device Lot Number: J0659R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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