MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 44IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122144162
Medical Device Problem Codes	Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
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 limited motion, constant pain, infection of original implant causing necessity of revisions, pain in leg and neuropathy in both legs.After review of medical records for mdr reportability, patient was revised to address pain and infection.Revision note stated, there was about 3 ml of very cloudy synovial fluid out which almost looked purulent.The hip was dislocated and did have a lot of fibrinous growth within the acetabular area.The stem was well fixed but found to have some osteolysis in the proximal femur.The patient had a lot of bone loss.It was mentioned that the sed rate and crp were elevated; however his aspiration was dry.There were no laboratory values provided.Doi: (b)(6) 2010; dor: (b)(6) 2016; (left hip).
Additional Manufacturer Narrative
(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.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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
Event or Problem Description
Ppf alleges loosening of cup, loosening of stem, metal wear/metallosis and elevated metal ions.

• Brand Name: ALTRX +4 10D 44IDX62OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7776259
• Report Number: 1818910-2018-66348
• Device Sequence Number: 1793876
• Product Code: LPH
• UDI-Device Identifier: 10603295016625
• UDI-Public: 10603295016625
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2018

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 Expiration Date: 04/30/2014
• Device Catalogue Number: 122144162
• Device Lot Number: DN7AR1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 01/29/2019
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 08/23/2018; 01/31/2019
• 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: 60 YR
• Patient Weight: 129