MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-058
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/21/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.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
The patient was originally an asr patient implanted (b)(6) 2007 and revised on (b)(6) 2009 to pinnacle products and has since been revised to further pinnacle products and these have also been revised.Asr surgery: asr xl implanted (b)(6) 2007.Asr revised (b)(6) 2009 ¿ stem remained in situ.1st pinnacle surgery: pinnacle cup, head, liner implanted (b)(6) 2009.Acetabular cup pinnacle multihole 58 ref: 1217-20-058.Ceramic femoral head ref: 1365-35-740.Metal insert pinnacle ref: 121887358.Pinnacle cup, head, liner revised (b)(6) 2010 - stem remained in situ.Reason for revision ¿ pain, dislocation of implant.Update ad 18 aug 2020: (b)(4) has been re-opened under (b)(4) due to claimsuite alerts received.Claimsuite alert alleges acetabular & femoral component loosening.Added associated contact, patient harm and concomitant products.Doi: (b)(6) 2009 - dor: (b)(6) 2010 (left hip).(b)(4) 1st revision.
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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: PINNACLE MULTIHOLE II CUP 58MM
• 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: 10483920
• Report Number: 1818910-2020-19286
• Device Sequence Number: 1240898
• Product Code: LPH
• UDI-Device Identifier: 10603295009658
• UDI-Public: 10603295009658
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 1217-20-058
• Device Catalogue Number: 121720058
• Device Lot Number: C16DE1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: DLT TS CER HD 12/14 36MM +12; PINNACLE MTL INS NEUT36IDX58OD; PINNACLE MULTIHOLE II CUP 58MM; UNKNOWN HIP FEMORAL STEM; DLT TS CER HD 12/14 36MM +12; PINNACLE MTL INS NEUT36IDX58OD; PINNACLE MULTIHOLE II CUP 58MM; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention