MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122136256
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
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.Initial reporter occupation: attorney.
Event or Problem Description
Ppf alleges infection, metal wear, metallosis and elevated metal ions after first revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: we received a ppf alleging infection, metal wear, metallosis and elevated metal ions after first revision.Doi (head and liner): on (b)(6) 2017.Doi (cup): on (b)(6) 2005.Dor: none reported.Right hip.Note: the primary construct was a mom.This was revised to a poly liner and ceramic head: the revision is reported in (b)(4).Therefore, it is possible that the mom-related aes reported for this construct (metal wear, metallosis and elevated metal ions) are lingering aes from the previous mom construct.However, this is not confirmed.Note: it is also unknown how long after the revision the infection occurred.No device associated with this report was received for examination.None of the information provided confirms the complaint.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combinations (122136256/c31718, 136536730/8451126 and 21722056/zd8fr1000).Based on the inability to find any additional related reports against the provided product code/lot code combinations it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time they were released for distribution.  the devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.

• Brand Name: ALTRX LIP LNR 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8276988
• Report Number: 1818910-2019-82222
• Device Sequence Number: 2357153
• Product Code: KWA
• UDI-Device Identifier: 10603295393184
• UDI-Public: 10603295393184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 04/30/2021
• Device Catalogue Number: 122136256
• Device Lot Number: C31718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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: Other