MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Hypersensitivity/Allergic reaction (1907); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Type  Injury  

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 Description

An article/literature was received entitled "increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ update 18 sep 2019.¿increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ was reviewed for mdr reportability.The study followed 404 primary total hip arthroplasties, including 258 ceramic-on-metal (com tha) and 146 ceramic-on-ceramic or ceramic-on-polyethylene (non-com tha).A pinnacle acetabular cup and summit cementless stem were used in both groups.The ceramic-on-metal operations used biolox delta modular head and ultamet liner while the non-ceramic-on-metal operations used a depuy head with either a depuy ceramic liner or marathon polyethylene liner.It is noted specific patient identifiers nor specific revision information was provided.The following adverse events were noted: dislocation occurred in 5 com tha and 2 non-com tha.All dislocations were corrected with closed reduction with no reported recurrence.1 com tha patient complained of a noisy hip with no evidence of intervention.1 com tha patient underwent a revision to address a pseudotumor.Multiple patients in each group developed elevated metal ion levels.There is no evidence of revision or intervention to address elevated levels.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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.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.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9163530
• MDR Text Key: 169845131
• Report Number: 1818910-2019-108060
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention