MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 1 D8 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130708100
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/29/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2010: the patient underwent a revision of a non-depuy tsa to a delta xtend rtsa on her right shoulder.On (b)(6) 2011: the patient was seen in office secondary to pain.The patient had shoulder aspiration performed with no fluid removed.The patient was also diagnosed via radiograph, with loosening at the bone to cement interface.On (b)(6) 2015: the patient was seen again secondary to pain.The patient again had aspiration performed to her shoulder, with no fluid at all removed.The patient also revealed that she fractured her right humerus around the prosthesis two or three years ago; it was treated nonoperatively and apparently healed.The surgeon reports this could explain the change in position of her implant at lease radiographically that may not mean it is loose and may be that it is changed based upon the fracture.On (b)(6) 2017: the patient was seen again in the office for shoulder aspiration with no fluid removed.On (b)(6) 2017: the patient was seen for blood work results.The results confirm no infection.The surgeon and patient agree to no revision and to follow-up yearly.Pmh: multiple sclerosis.Doi: (b)(6) 2010 (revision from non-depuy implant to depuy implant).Doe: (b)(6) 2011 (joint aspiration-right shoulder).Doe: (b)(6) 2015 (joint aspiration-right shoulder).Doe: (b)(6) 2017 (joint aspiration-right shoulder).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• Brand Name: DXTEND MBLOC HUM EPI 1 D8 STD
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9738474
• Report Number: 1818910-2020-05576
• Device Sequence Number: 16232013
• Product Code: KWS
• UDI-Device Identifier: 10603295027102
• UDI-Public: 10603295027102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: MM 49-12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130708100
• Device Catalogue Number: 130708100
• Device Lot Number: 5019752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 76