MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PIN LNR CONS NEUT +4 36IDX60OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121836660
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/01/2019
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
Event: a constrained liner detailed above was implanted successfully into the pinnacle cup as per surgical technique, however when reducing the femur to introduce the femoral head into the liner it was noted by the surgeon that a section of the liner that sits proud of the pinnacle shell had doubled back on itself and impeded the femoral head from entering the constrained liner and causing damage to the constrained liner.It was commented by the surgeon that the strength of the polyethylene should not allow this to happen.The liner had to be removed ¿ with great difficulty ¿ greater damage was caused to the liner on removal as a section had to be cut with osteotomes to release it from the cup.A new constrained liner was inserted and surgery was completed.Surgery time was extended by 45 mins approx.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Retracting (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: examination of the returned device has not identified product error regarding the reported event.It has been returned badly damaged from the extraction process.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.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 : 751757.Device history batch: null.Device history review: no deviations or anomalies identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PIN LNR CONS NEUT +4 36IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8540291
• Report Number: 1818910-2019-91362
• Device Sequence Number: 10840830
• Product Code: KWZ
• UDI-Device Identifier: 10603295012146
• UDI-Public: 10603295012146
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2019

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: 121836660
• Device Lot Number: 751757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 04/26/2019; 05/08/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 04/29/2019; 05/06/2019; 05/10/2019
• 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
• Patient Age: 66 YR