MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY XL TAPER SLEEVE ADAPTOR; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Muscle Weakness (1967); Pain (1994); Cramp(s) (2193)

Event Date 07/02/2014

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510# number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.

Event Description

Asr revision, asr resurfacing - left, reason(s) for revision: unknown.Surgeon confirmation form received (b)(6) 2014.Revision reasons added.Revision date amended.Reason(s) for revision: alval / soft tissue reaction, high metal ion level.Update (b)(6) 2016: added patient name, initials, gender and dob.Added additional surgeon.Taken from updated asr legal claim (b)(6) 2016 ((b)(4)).Update (b)(6) 2017: litigation received.Litigation alleges high metal ions.It was also reported that after the revision surgery, patient is still experiencing residual pain, frequent episodes of cramps and muscle weakness.Unknown stem and sleeve have been added.Added complainant information.This was updated on jul 21, 2017.

Manufacturer Narrative

Asr revision asr resurfacing - left reason(s) for revision: unknown surgeon confirmation form received (b)(6) 2014.Revision reasons added.Revision date amended.Reason(s) for revision: alval / soft tissue reaction, high metal ion level update (b)(6) 2016: added patient name, initials, gender and dob.Added additional surgeon.Taken from updated asr legal claim (b)(6) 2016 (pd (b)(6) 2016) update (b)(6) 2017: litigation received.Litigation alleges high metal ions.It was also reported that after the revision surgery, patient is still experiencing residual pain, frequent episodes of cramps and muscle weakness.Unknown stem and sleeve have been added.This was updated on (b)(6) 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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 will be filed as appropriate.

Manufacturer Narrative

Asr revision asr resurfacing - left reason(s) for revision: unknown surgeon confirmation form received (b)(4) 2014.Revision reasons added.Revision date amended.Reason(s) for revision: alval / soft tissue reaction, high metal ion level update (b)(4) 2016: added patient name, initials, gender and dob.Added aditional surgeon.Taken from updated asr legal claim (b)(4) 2016 (pd (b)(4) 2016) update (b)(4) 2017: litigation received.Litigation alleges high metal ions.It was also reported that after the revision surgery, patient is still experiencing residual pain, frequent episodes of cramps and muscle weakness.Unknown stem and sleeve have been added.This was updated on (b)(4) 2017.Update (b)(4) 2017: litigation record received.It was stated that the chromium-cobalt level were above 7ug/l.Added complainant information.This complaint was updated on (b)(4) 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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 will be filed as appropriate.

Event Description

Update oct 10, 2017: litigation record received.It was stated that the chromium-cobalt level were above 7ug/l.Added complainant information.This complaint was updated on oct 19, 2017.

• Brand Name: UNKNOWN DEPUY XL TAPER SLEEVE ADAPTOR
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6734021
• MDR Text Key: 80747648
• Report Number: 1818910-2017-21584
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR