MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REUNION GLENOSPHERE; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Arthralgia (2355); Joint Dislocation (2374)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that patient came to office with shoulder pain, heard "pop".Took x-rays, saw an infection, dislocated bone.(b)(4) created for dislocation.

Manufacturer Narrative

Referring to the product inquiry all reported products are considered primary products.The reported items were not returned to stryker.The review of the product history (including the sterilization certificate) of the reported implants revealed no conspicuities.No deviation was found in the sterilization and packaging processes.The items were documented faultless prior to distribution.Further, the expiration date of all reported products was not exceeded.Clinical comments from ¿clinical evaluation reunion rsa-cle 01.2¿ (author: dr.H.Mueckter): ¿in most cases reverse arthroplasty of the shoulder joint (indicated for any degenerative arthropathy) represents the last step of a series of therapeutic measures (e.G.Injections of cortisone or local anesthetics) or previous surgeries (e.G.Failed rotator cuff repair or previous arthroplasty).All those procedures bear a high risk of pre-contamination and/or occult infection of the surgical field prior to surgery, which may explain the relatively high risk of postoperative infection.In general, infections after orthopaedic procedures in shoulder arthroplasty (¿) are common (approx.1 - 5 %, exceptionally up to 10 %).The reasons for such infections are multiple (e.G.Poor soft tissue conditions, preexisting germ load, diabetes mellitus, immunodeficiency, germ load in the or, insufficient pre-operative disinfection of the surgical field, careless handling of the surgeon and/or the or-staff, postoperative hematoma, wound healing complications, insufficient patient compliance, particularly smoking patients etc.).In many cases such an infection will be self-limiting due to low germ load and low pathogenicity (s2).But, in more than 1 % of the cases specific surgical and/or medical measures (e.G.Revision surgery and/or antibiotics) will be required for treatment (s3).Only in exceptional cases such an event will result in severe permanent harm (e.G.Significant loss of the shoulder function) (s4).Particular in the case of a deep infection, which is resistant to any therapeutic measures, explantation of the humeral stem and insertion of a spacer made from pmma with antibiotics may be required (s3) or the procedure is finalized as simple resection arthroplasty resulting in functional palsy of the shoulder joint (s4).¿ no additional information such as medical records, x-rays or surgery reports was provided although repeatedly requested.This also applies to the questionnaire ¿(b)(4) infection complaints checklist customer¿, which was sent out as mandatory in infection cases; the (filled out) form was not returned, no reply from the sales rep was received.Likewise, no further information regarding the kind of infection (e.G.Microbiological germ-proof with resistogram) was provided.We have received no information regarding other potential sources of infection, including but not limited to the patient or the facility.If the required data won't be provided, a reasonable investigation and root cause analysis is not possible and any statement would furthermore only be based on assumptions.Based on the above and by taking into consideration that the reported products were documented faultless prior to distribution, a review of the event in line with ¿(b)(4) infection complaints checklist investigator¿ was deemed not expedient.A deficiency of the devices could not be determined.However, based on the limited information given the root cause of the reported event could not be determined, as well.Review of complaint history, capa databases, risk analysis and the labelling did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the event for the subject products.No non-conformity was identified.Device not returned.

Event Description

It was reported that patient came to office with shoulder pain, heard "pop".Took x-rays, saw an infection, dislocated bone.(b)(4) created for dislocation.

• Brand Name: UNKNOWN REUNION GLENOSPHERE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6746291
• MDR Text Key: 81113907
• Report Number: 0008031020-2017-00454
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59