MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-156
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 on (b)(6) 2019 the patient underwent a revision surgery due to the ¿prosthesis fracture¿ of the pinnacle implant and subsequent ¿replacement of the stem and of the polyethylene liner¿.The above impacted implant was implanted on (b)(6) 2010 after a revision and replacement of the asr implant that the patient received on (b)(6) 2008.Doi: (b)(6) 2010.Dor: (b)(6) 2019; (right hip).
Event or Problem Description
Claim letter alleges reason for revision is periprosthetic fracture of the stem.Doi: (b)(6) 2010.Dor: (b)(6) 2019.Right hip (2nd revision).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  corrected: a2 (dob), d6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.H10 additional narrative: added: b1 corrected: h6 (device).
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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.H10 additional narrative: removed: (2988) naturally worn as this was reported in error.
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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.Corrected: h6 (device).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.
Event or Problem Description
Litigation alleges prosthetic fracture.Plaintiff is seeking full compensation for all the damages that had caused her such as permanent biological injury, impaired mobility, limited adl, joint insufficiency, financial losses and social interactions due to defective and lack of safety products implanted.

• Brand Name: PINN MAR +4 10D 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10028743
• Report Number: 1818910-2020-11727
• Device Sequence Number: 3752322
• Product Code: LPH
• UDI-Device Identifier: 10603295014591
• UDI-Public: 10603295014591
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/26/2020

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: 1219-36-156
• Device Catalogue Number: 121936156
• Device Lot Number: DH2F91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 07/22/2020; 07/28/2020; 07/28/2020; 07/30/2020; 01/12/2021
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 07/07/2020; 07/24/2020; 07/30/2020; 07/30/2020; 08/05/2020; 01/25/2021
• 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: ARTICULEZE M HEAD 36MM +8.5; CORAIL2 NON COL HO SIZE 13; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE BONE SCREW 35 MM; PINNACLE MULTIHOLE II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR