MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121711056
Medical Device Problem Codes	Degraded (1153); Difficult to Remove (1528); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hematoma (1884); Pain (1994); Discomfort (2330)
Date of Event	10/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Pfs and medical records received.Pfs alleges that patient suffered capsulectomy, and hematoma.After review of medical records for the mdr reportability, patient was revised to address synovitis and metallosis.Revision notes reported of inflammatory look fluid, graying of the tissue, metallosis within the joint and some corrosion at the taper.It was also stated in the revision that due to corrosion , there was some cold welding of the liner within the cup.Clinical visits reported of pain, limps, grinding type sensation, severe discomfort and trochanteric bursitis.It was also stated that patient had an elevated cobalt-chromium serum levels, however, there is no laboratory results provided.Cup will be reported since it was removed.Doi: (b)(6) 2008; dor: (b)(6) 2012; left hip.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Udi: (b)(4).
Event or Problem Description
Ppf alleges metal wear.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 100 HA ACET CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7163385
• Report Number: 1818910-2018-50088
• Device Sequence Number: 16620182
• Product Code: LPH
• UDI-Device Identifier: 10603295009085
• UDI-Public: 10603295009085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/05/2017

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 Expiration Date: 09/09/2017
• Device Catalogue Number: 121711056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/31/2018; 12/14/2018; 12/10/2019
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/01/2018; 12/17/2018; 01/09/2020
• 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: 53 YR
• Patient Weight: 99