MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330)
Date of Event	12/15/2011
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
Letter from express solicitors ref (b)(4).On (b)(6) 2009- total right hip replacement.(b)(6) 2010 - patient complained to gp of increased pain in right leg anf hip.X-ray and blood tests were normal.On (b)(6) 2011 - aspiration of right hip.Aspirate was normal.Patient continued to experience pain and discomfort.Also suffered redness and swelling in right lower limb.(b)(6) 2011 - blood tests confirmed raised cobalt and chromium.(b)(6) 2011 - gp noted symptoms were disabling and patient was keen for revision.(b)(6) 2011 - revision.Now making steady progress but still suffers from pain.Solicitor requesting the following documents be made available for each of the products pinnacle, apex, corail, articuleze; product specifications, design documents, safety and safety testing of the products.Documents relating to investigations of reports of increased blood ions.Doi: (b)(6) 2009; dor: (b)(6) 2011; right hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary: conclusion and justification status: a review of complaint databases did not identify any anomalies.A review manufacturing records was not required per (b)(4).The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR HA ACET CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7241061
• Report Number: 1818910-2018-52744
• Device Sequence Number: 10983506
• Product Code: LPH
• UDI-Device Identifier: 10603295009153
• UDI-Public: 10603295009153
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 121712050
• Device Lot Number: D3JF41000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 02/09/2018
• 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: 76 YR