MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122140460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Pinnacle litigation records received alleging elevation of blood cobalt and chromium levels, sharp pains, psoas tendinitis (negative for infection), metal reaction, trunnionosis, cicatrix, physical injury and disability, lack of mobility, weakness of the left leg, difficulty walking laterally, limited mobility and emotional distress.It was noted that during the procedure, the surgeon noted a light greenish cloudy fluid and destruction of the abductor mechanism.There was a pseudotumor due to the metal-on-metal reaction and a complete synovectomy was needed to debride the hip of metal particles.There was gross corrosion with black material at the head-neck junction as well as on the head-neck taper.The liner is poly.Doi: (b)(6) 2006 (stem), doi: (b)(6) 2011 (liner and head), dor: (b)(6) 2017, left 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 will be filed as appropriate.

• Brand Name: ALTRX +4 NEUT 40IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8627945
• Report Number: 1818910-2019-94157
• Device Sequence Number: 19391232
• Product Code: LPH
• UDI-Device Identifier: 10603295016618
• UDI-Public: 10603295016618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 122140460
• Device Lot Number: 126522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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: 62 YR