MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712052
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/22/2012
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
Revision due to mass in right groin.Reported - severe pain, grinding & patient struggles to straight leg raise.Walking distance 100yards.Oxford score 12/48.Doi: (b)(6) 2005; dor: (b)(6) 2012; right hip.Update (b)(6) 2018.Pinnacle spreadsheet receive.Added patient details, affected side, added product record for the acetabular cup and corail.Corrected doi.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the complaint, originally (b)(4), was re-opened upon receiving further information from kennedys which was: update 12 jan 2018.Pinnacle spreadsheet receive.Added patient details, affected side, added product record for the acetabular cup and corail.Corrected doi no products or patient records were ever returned.A complaint search and dhr review were conducted previously, the results of which were documented in (b)(4), a copy of which can be found attached in this complaint in the notes and attachment section.This investigation is only reviewing the new information that has since been provided.No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: e1, h6 (health effect - impact code).Corrected: d2a, d2b, d3, d4 udi, d6a, d6b, e2, g4 [pma/ 510(k)].D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Recaptured codes on h6 (health effect - clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN SECTOR HA ACET CUP 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7243523
• Report Number: 1818910-2018-52788
• Device Sequence Number: 1043876
• Product Code: LPH
• UDI-Device Identifier: 10603295009160
• UDI-Public: (01)10603295009160(10)Z2BG41000
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,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: 121712052
• Device Lot Number: Z2BG41000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/12/2018; 02/08/2018; 01/23/2026
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/06/2018; 02/08/2018; 01/26/2026
• Date Device Manufactured: 09/27/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown