MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ASPHERE M SPEC 12/14 36 +1.5; HIP FEMORAL HEAD

Catalog Number 136551100

Device Problems Corroded (1131); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 11/07/2013

Event Type  Injury  

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 Description

Litigation record received.Litigation alleges severe pain, discomfort and adverse reactions to high levels of metal debris.Doi: (b)(6) 2010; dor: (b)(6) 2016; left hip.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf and sticker sheets received.Ppf alleges elevated metal ions confirmed in medical records.

Manufacturer Narrative

(b)(4).

Event Description

Pfs alleges pain, discomfort, limited mobility and elevated metal ion levels.After review of medical records for mdr reportability, it was indicated that the patient was revised to address pain and complications due to the failed hip implant.Revision notes report stained synovium consistent with metal debris and taper corrosion at the head and neck junction.Clinic visits reported that patient fell in (b)(6) 2016.Mri revealed fluid around hip joint.Lab results shows cobalt ion levels above 7ppb.

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: ASPHERE M SPEC 12/14 36 +1.5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7163913
• MDR Text Key: 96353831
• Report Number: 1818910-2018-50190
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2015
• Device Catalogue Number: 136551100
• Device Lot Number: 3115769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2018
• Date Device Manufactured: 04/16/2010
• 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
• Patient Age: 72 YR
• Patient Weight: 102